MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 5.2 ML, ADMIN SET W/2 CHEMOLOCK¿; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL3520

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.If additional information will become available, a supplemental report will be submitted.

Event Description

The customer reported that an administration set had a hole in the top of the white plastic of the drip chamber and chemotherapy continue to drip despite clamping.There was unknown patient involvement and unknown adverse event.

• Brand Name: 40" (102 CM) APPX 5.2 ML, ADMIN SET W/2 CHEMOLOCK¿
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest 60045 ; 2247062300
• MDR Report Key: 8190601
• MDR Text Key: 131496528
• Report Number: 9617594-2018-00230
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709057036
• UDI-Public: (01)00887709057036(17)231001(10)3793043
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: CL3520
• Device Catalogue Number: CL3520
• Device Lot Number: 3793043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1